However, the health ministry is considering retaining some of the FDC-based cough syrups to prevent shortage.
Overall, the Central Drugs Standard and Control Organisation (CDSCO) has readied a list of 19 FDCs, which was finalised by the expert committee constituted under the chairmanship of Dr. M S Bhatia, professor and head, Department of Psychiatry, University College of Medical Sciences.
The list has now been submitted to the ministry of health and family welfare.
FDC, or cocktail medicines, combine more than one drug in a single pill, and have increasingly come under the government lens as combinations of drugs, such as antibiotics, can result in resistance to the drug in the disease-causing organism.
The list includes Sumo, Nicip, D Cold Total, Vicks Action 500 Advanced, cough syrups Tedykoff, Grilinctus, Codistar, Tossex, Ascoril C, Piriton expectorant and antibiotic ointment Clindamycin, among others. The pharma companies manufacturing these drugs include Alkem, Cipla, Reckitt Benckiser, Procter & Gamble, Mankind Pharma, Abbott, Glenmark and GlaxoSmithKline, among others.
“While the list of 19 FDCs is final, it includes a lot of cough syrups. If the ban is announced, it may wipe out a major share from the market, leading to a shortage of branded cough syrups. Hence, we are reconsidering some of the FDCs,” a government official from the ministry said. “We are considering retaining two to three combinations and ban other products. For instance: Tixylix syrup and Corex may continue.”
The official said that as “these cocktail medicines are not found in any developed country, India will take a call soon”.
The stakeholders, under the Bhatia committee, have submitted the information on the rationality, safety and efficacy with regard to the said FDCs.
The expert committee was constituted by the central government after the judgment of the Supreme Court in 2017.
The government, in 2016, had started a drive to filter out many of these FDCs from the Indian pharmaceutical industry by banning around 350 of them, impacting over 2,700 branded drugs.
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Originally published at www.news18.com